New RCT finds vitamin D and simvastatin may reduce migraines

A recent randomized controlled trial discovered that vitamin D supplementation in conjunction with simvastatin is an effective treatment for migraine headaches.

Migraines affect approximately 18% of women and 6% of men in the U.S. each year, ranking as the eighth highest cause of disability worldwide. Migraines are characterized by intense throbbing or a pulsing sensation in one area of the head that lasts from 2 to 72 hours. This pain is often accompanied by nausea, vomiting and extreme sensitivity to light and/or sound.

Nearly one third of people who experience migraine headaches perceive an aura, or a warning sign that a migraine is about to occur. The aura varies from flashes of light, blind spots to numbness in the arms and legs.

The etiology behind migraines remains unclear; though it is considered to be a neurological disorder. Individuals who experience migraines are also at an increased risk for vascular disease. Current treatment options are limited due to their intolerable side effects, including undesirable weight gain or loss, low blood pressure, cognitive slowing and fatigue. Therefore, more tolerable treatment options are needed.

Researchers from Boston, Massachusetts, recently conducted a randomized controlled trial to evaluate the efficacy of treating migraines with simvastatin and vitamin D. Simvastatin is a statin; thus, it’s best known for lowering cholesterol, though it also improves vascular health. In addition, vitamin D has anti-inflammatory properties that have also been shown to improve vascular health.

In the current study, researchers randomly assigned 57 adults with episodic migraines to a placebo group or treatment group. The treatment group received 20 mg tablets of simvastatin twice daily plus 2,000 IU of vitamin D daily; whereas, the placebo group received matching placebo tablets and capsules. All participants were asked to keep their migraine treatment regimen stable throughout the study.

The study lasted for 36 weeks, consisting of a 12-week pre-randomization (weeks -12 to 0), followed by 24 weeks of intervention (weeks 1-12 and weeks 13-24). The researchers compared how many migraines the participants had prior to the intervention (during weeks -12 to 0) to the number of migraines they experienced post-intervention. Throughout the study, participants recorded the onset, duration, severity and symptoms of migraines, along with medication use in diaries. The participants attended four clinic visits, in which they were interviewed, had blood drawn and completed standardized questionnaires on migraine disability and non-headache body pain.

After 12 weeks of intervention (weeks 1-12), participants in the treatment group demonstrated a reduction of migraine days from baseline with a change of -8 migraine days. This decrease was significantly greater in comparison to the placebo group, which experienced a +1 migraine day (p < 0.001). After weeks 13-24, the treatment group experienced a change of -9 migraine days; whereas the placebo group experienced a +3 migraine days (p < 0.001). In the treatment group, 8 participants (25%) experienced a 50% reduction in the number of migraine days at 12 weeks and 9 participants (29%) experienced a 50% reduction at 24 weeks. Only 1 patient in the placebo group experienced a 50% reduction.

It’s important to note that the symptoms, such as migraine duration, migraine severity, presence of nausea and/or muscular pain, did not significantly change in either group.

The researchers questioned participants regarding adverse events that occurred during the study, because, as mentioned earlier, the main issue with current migraine medication options is the intolerable side effects. However, no serious adverse effects due to treatment occurred.

The researchers concluded,

“In summary, this is the first double-blind placebo-controlled randomized trial evaluating simvastatin 20 mg twice daily plus vitamin D 1000 international units twice daily for prevention of episodic migraine. The results demonstrate that this therapy reduces the number of days with migraine and use of abortive medications.”

They went on to state,

“The effect size of 30% fewer migraine days is a magnitude of reduction in migraine days that exceeds the effect of other agents considered to be clinically significant for migraine prevention.”

While this study presents very promising findings, it’s important to consider its limitations. First, this RCT was relatively small. Larger and more diverse populations are needed. In addition, the study did not isolate the effects of vitamin D alone or simvastatin alone. Therefore, one cannot conclude the benefits attributed to vitamin D or simvastatin. Lastly, the participants were asked to continue their regular medication for migraines. Thus, the study’s findings do not permit patients to replace their current migraine medication with simvastatin and vitamin D.